Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult… (NCT06517732) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation
Russia107 participantsStarted 2024-07-26
Plain-language summary
ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Patients who provide written informed consent form (ICF) to participate in the study.
✓. Male and female.
✓. ≥ 18 years old.
✓. Diagnosis of moderate or severe HS (Hurley stage and IHS4).
✓. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
✓. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.
Exclusion criteria
✕. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
✕. Participation in an ongoing clinical trial.
✕. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
✕. Clinically significant infection exacerbation, including active tuberculosis.
✕. Patients with active inflammatory bowel disease (IBD).
✕. Age \<18 years.
✕. Pregnancy and breastfeeding.
What they're measuring
1
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)